The following career opportunities were posted this week at DNAjobs.com. For each position, I have listed a short description and a link for more information.
As always, I wish you tremendous success in your searching!
Jason
Research Technician - Molecular Biology
(US-Ohio) A full-time position for a research technician is available in a developmental neurobiology laboratory at the Medical College of Ohio. This person will join our lab to assist in studies on the impact of exposure to drugs of abuse on the development of the nervous system. The lab group utilizes a number of approaches, including electrophysiology, biochemistry, calcium imaging, microscopy, and molecular cloning. This technician will be primarily responsible for subcloning genes and for carrying out site-directed mutagenesis procedures. Additionally, this person will prepare standard solutions and maintain laboratory supplies. Requirements for the position include: B.A./B.S. degree in Biology or a related field (M.S. degree in Biology or a related field or B.S. degree with experience preferred); Excellent general laboratory skills (preparing solutions, organizing reagents, assisting with experiments); Experience with molecular biology techniques (preparation and detection of DNA and RNA, subcloning, site-directed mutagenesis.
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Clinical Project Manager (Non-MD) - B
(US-Illinois) Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Project Manager (Non-MD) - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Manage Phases I & IV domestic and international clinical research studies. Responsibilities include protocol design and development, case report form development, contract negotiation, site recruitment, support program management for project reviews, budget and timeline development, establish relationships with outside vendors, medical consultants and partners, provide IND and NDA summary reports, interface with interdisciplinary teams, monitor project timelines, develop project management tools, and provide project presentations. BS/MS Preferred. Person needed ASAP - we are in critical need. Position will assist with the IND and NDA summary reports, not be solely responsible for them. 3+ years in a related technical discipline. 1+ year in clinical research and study budget management.
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Clinical Research Associate Sr. - C
(US-Illinois) Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Research Associate Sr. - C with the following qualifications: REQUIRES 5+ YEARS EXPERIENCE Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRF's, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CRO's. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. BS Degree in the sciences is required.
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Research Scientist-Formulations
(US) Develop and characterize formulations to support small molecule drug discovery and development programs. The position requires hands on laboratory work. Job Responsibilities: Establish a formulation development and testing lab. Develop prototypes of formulations (solid and liquid dosage forms for injection and oral dosing). Characterize new drug substances and formulations with respect to relevant thermal, solid state, solubility, and stability properties. Hands on operation and maintenance of analytical instruments. Effectively transfer research formulations developed in the lab to the manufacturing facilities. Assist with defining QC specifications / audits / generation of documents for regulatory agencies. Education/Experience: Ph.D. with a minimum of 3 years industry experience developing formulations for injection and oral dosing (capsule and tablet) of small molecules.
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Clinical Pharmacology/Clinical Research
(US) Two (2) Positions exist! Do you have 5-10 years of Clinical Development experience in a CRO or biopharmaceutical company? Do you have a PharmD or a Phd? Have you experience in the therapeutic area of Diabetes? Infectious Disease? If so - Read on. An opportunity exists to join a rapidly expanding, financially stable company in the New England area. Your track record of success in leading clinical programs will now provide you with the opportunity to develop and implement early clinical development programs to include the clinical pharmacology component. Your experience will allow you to manage this early clinical stage product through the clinical/regulatory process and into approval. You will be the recognized expert in all clinical pharmacology issues/questions. Your qualifications must be a PhD / PharmD with significant experience in a clinical pharmacology related discipline. Global project management experience is a must as well as budgetary/financial responsibilities. A track record of leading a pharmaceutical development is a necessity.
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Partner / Chief Business Officer
(US) We are seeking a highly motivated and self-sufficient Business Partner to serve as an interim or permanent Chief Business Officer (CBO). Required experiences: •Start-up company •Business plan review •Successful negotiations with investors •Licensing and partnership agreements •MBA and or Ph.D. •Direct experience in biotechnology industry is a plus Primary responsibilities include: •Raise capital from angel investors, venture capitalists, investment bankers, corporate investors, and the federal government •Acquire new clients •Structure business alliances - Initiate and structure licensing and partnerships agreements •Direct marketing and sales activities •Introduce products and services to domestic and international markets •Provide investment capital to company Applicants will also be required to: •Obtain Intent-To-Purchase Agreements for Potential Customers •Maintain superior knowledge of market conditions and competitive intelligence
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Clinical Research Associate (CRA) - C
(US-Illinois) Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Research Associate (CRA) - C with the following qualifications: REQUIRES 5+ YEARS EXPERIENCE. Member of the clinical team responsible for conducting Phase I - IV single or multi center studies according to Federal Regulations and ICH guidelines. Responsible for assisting senior staff in planning study conduct, designing case report forms (CRF's), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions. Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRF's from study sites, processing CRF's including data cleanup and classification of data, and completion of study summary.
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Manager Sales and Marketing
(US) Manager Sales & Marketing, North America Open Date: Aug 20, 2003 Close Date: Feb 11, 2004 Job Location: Virtual - Territory NE United States Job Category: Sales & Marketing - Manager. SUMMARY: Medical device company will be launching its latest generation fluorescence endoscopy system into the North American markets for lung (bronchoscopy) mid-2004 followed by Colon (Colonoscopy). Consequently, the company is in the process of evaluating its sales, marketing and service strategies for their product throughout North America. In order to drive and support sales through direct sales and distribution, co-ordinate North American activities for marketing, sales and service, co- ordinate XXXX's participation in medical trade shows and exhibitions, and manage XXXX's overall business in North America, the company is looking to hire a Sales and Marketing Manager. Although North America is the area that the Manager will spend the majority of time, the successful candidate will also have responsibility for XXXX's business in other related markets.
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Chemist: Oligonucleotide Synthesis/Nucleic Acid
(US-Arizona-Phoenix) Synthetic chemist with emphasis in nucleic acid synthesis at the postdoctoral or lead chemist level. Responsibilities include large scale synthesis of modified nucleotide/nucleoside analogs. A strong background in analytical methods for nucleic acid characterization is strongly preferred. Position level will be determined by the level of experience.
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Regulatory Affairs Manager
(US-Minnesota) Our client is recognized as a leader in the markets it serves. This medical device company, located in Minnesota, has an immediate need for a Regulatory Affairs Manager. This newly created position will report to the VP of Quality and Regulatory Affairs. DUTIES & RESPONSIBILITIES: *Oversee preparation for both US and international regulatory submissions and registrations *Manage regulatory affairs staff members; 2 direct reports *Interact & negotiate with FDA and other worldwide regulatory agencies *Collaborate with Clinical Affairs and product development teams and establish appropriate strategies for obtaining product approvals *Review/sign-off/provide guidance for: document change orders, labeling issues, regulatory submissions, SOP's & procedures REQUIREMENTS: *Bachelor's degree; Master's degree preferred *5+ years medical device regulatory experience *MUST HAVE hands on experience with IDE, PMA, and 510k submissions *Direct experience with medical device manufacturing and/or product development *Demonstrated knowledge/experience with US and international device regulations
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